BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2260719 · Received September 22, 2011

    Report

    Report Number
    2210968-2011-00971
    Event Type
    Injury
    Date Received
    September 22, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE PUBLISHED IN THE AMERICAN JOURNAL OF SURGERY, 2011, 202, 28-33, TITLED PREDICTORS OF MESH EXPLANTATION AFTER INCISIONAL HERNIA REPAIR THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR AND MESH WAS USED. THE MESH WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention